低pH孵放法对人免疫球蛋白中病毒的灭活效果及制品质量的影响

目的 :探讨低 pH孵放法对人免疫球蛋白制品中加入的指示病毒的灭活效果及对其主要质量指标的影响 ,以完善生产工艺 ,使制品更安全有效。方法 :取经低温乙醇法制备的人免疫球蛋白原液作样品 ,分为 2组 ,分别调 pH至 4 .1±s 0 .3和6.90±0 .10 ,经除菌 ,分别按与样品体积比 1∶9的比例加入Sindbis病毒 (滴度 8.5LogTCID·mL- 1)与VSV病毒 (滴度 8.67LogTCID·mL- 1)培养液 ,孵放 (2 4 .0± 1.0 )°C ,并于 0 ,7,14,2 1d取样检测 2种指示病毒滴度 ,同时检测制品单体 +二聚体含量、HBs抗体、白喉抗体效价、制品纯度及观察制品热稳定性。结果 :经低 pH孵放法〔pH 4 .1± 0 .3,(2 4 .0±1.0 )°C〕 ,孵放 2 1d)灭活 ,VSV病毒及Sindbis病毒滴度下降均达 6.5logTCID5 0·0 .1mL- 1以上 ,且制品主要几项质量指标未见影响。结论 :低 pH孵放法对人免疫球蛋白制品病毒灭活效果好 ,对制品质量无影响

Inactivation effect of incubation at low pH value on virus and influence of it on quality of human immunoglobulin

AIM: To exploxe the inactivation effect of incubation at low pH value on the marker viruses and the influence of it on main quality indicators of human immunoglobulin to improve production procedure and ensure even more safety and effectiveness of human immunoglobulin. METHODS: Two samples were taken from human immunoglobulin prepared by freezing ethanol precipitation as samples and adjusted the pH values to 4.1±0.3 and 6.9±0.1 , respectively. After the bacteria were removed and human immunoglobulin respectively mixed with Sindbis (8.5LogTCID·mL -1 ) and VSV (8.67LogTCID·mL -1 ) according to a ratio of 1∶9 (V/V) and incubated at (24.0 ± 1.0) °C , then detected the virus titer, monomer, dimmer, purity, as well as antibodies to HBs, diphtheria and stability at 0, 7, 14 and 21 d after incubation. RESULTS: Both titers of VSV and Sindbis viruses decreased by more than 6.5Log TCID50·0.1mL -1 , and no influence on the main quality indicators of human imunoglobulin was observed. CONCLUSION: The incubation at low pH value shows good inactivation effect on viruses but no influence on the quality of human immunoglobulin.